Intellectual Property Protection
There is no legal protection for pharmaceutical products in Qatar. Despite recent progress on copyrights and trademarks, Qatar has yet to approve and implement a modern patent law providing adequate and effective patent protection for pharmaceutical products. This is in marked contrast to Qatar's Gulf Cooperation Council (GCC) neighbors, Saudi Arabia and Bahrain, which provide patent laws offering a basic level of protection to pharmaceuticals.
The market is dominated by the Government sector, which is prone to buying unauthorized (pirate) copies of new products, including top-selling US pharmaceuticals in a number of therapeutic categories. One U.S. pharmaceutical company representative who raised the patent piracy issue was told by a Ministry of Health official that "patents don't interest us" and "we will buy from the cheapest source."
PhRMA appreciates the strong U.S. government support which contributed to reversal of the Ministry of Health's approval in recent weeks of 10-12 copies of U.S. patented products from a Jordanian company. The affected US companies, the new Gulf pharmaceutical association, PhRMAG, as well as PhRMA, all raised complaints to the ministers of health and industry. US Ambassador McKune also asked that the pirate products be prevented from entering the market. We now understand that Qatar has agreed that the copied pharmaceutical products will not be imported, will not be sold in the retail market and will not be stocked in hospitals.
The piracy of US pharmaceuticals continues despite assurances to US officials over the years that the Ministry of Health would not purchase pirate products. There is also a report that previous Emir approved a decree in 1995, stating that Qatar would abide by the principles of the proposed GCC Patent Law, taking companies' intellectual property rights into its procurement decisions. Unfortunately, Qatar joined other GCC countries in supporting GCC Resolution No. 11, calling for a five year delay in patent protection for pharmaceuticals, at least until 2005.
While there is a strong desire to purchase quality products, budgetary pressures and an apparently indiscriminate drive for "cost containment" appear to be leading toward the introduction of "cheap" pirate products as a financial "short cut." US companies have pointed out that subsequent laboratory testing of these pirate products has shown them to be substandard or out of specification, raising questions about the true "savings" and risks posed to patients. Research companies have explained to health officials that they do not oppose the use of legitimate generics, provided the meet the strict quality standards.
Other Trade Barriers
Due to circumstances that are not entirely clear, Qatar lags behind many countries in the region regarding new product registration. Research based industry notes that countries such as Bahrain, Kuwait and Cyprus-all regional neighbors, conduct thorough reviews of new American products and are able to do so in as few as 90 days after submission.
It is prudent to demand strict pharmacovigilance standards for products originating from certain countries where Good Manufacturing Practices (GMP) may not be in force. In this case Qatar's "2 year rule" makes sense. It is overly cautious, however, to impose long pharmacovigilance requirements on pharmaceuticals that have been approved in major "reference" countries and in which the products are in circulation-used often by millions of patients. American research based companies submit extensive GMP, clinical and laboratory documentation, and almost all submissions are made after prior FDA or major reference country regulatory approval. There should be a "fast track" procedure for New Chemical Entities (NCE's) and their line extensions. Patients in Qatar should not have to obtain the latest innovations from abroad or from neighboring countries.
Qatar also allows GCC ("local") producers discriminatory and protectionist 20% price allowances in Government tenders-at a time when it is trying to save money.
Potential Exports/Foreign Sales
PhRMA estimates annual piracy losses to US companies in the range of $10 million to $15 million. While we are optimistic that Qatar will live up to recent commitments to keep copied pharmaceutical products out of the market, we appreciate continued U.S. Government review of the situation.